Coronary computed tomographic angiography with CT - derived fractional flow reserve: A non-invasive coronary computed tomography angiography (CCTA) protocol that visualizes coronary anatomy to evaluate the presence, location, and severity of atherosclerotic stenosis, coupled with CT-derived fractional flow reserve (CT-FFR) analysis-a computational fluid dynamics method applied to CCTA datasets-to assess the hemodynamic significance of identified stenoses and identify lesions likely to induce myocardial ischemia.
Study summary
This study aims to investigate the guiding value of coronary CTA combined with CT-FFR in diagnostic and treatment decision-making for emergency chest pain patients at moderate risk, as well as its impact on clinical outcomes. Through a prospective multicenter randomized controlled trial, this research compares the preventive effects of early application of this technology versus standard care on major adverse cardiovascular and cerebrovascular events (MACCE), with the goal of optimizing the diagnostic and treatment processes for emergency chest pain patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age≥18 years；
2. Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD)；
3. HEART-score \>3 (according to http://www.heartscore.nl/)；
4. Signed written informed consent.
Exclusion Criteria:
1. Inability to obtain informed consent；
2. Acute Coronary Syndromes (ACS) requiring urgent revascularization；
3. Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG;
4. Concomitant severe congestive heart failure (New York Heart Association \[NYHA\] class III-IV or left ventricular ejection fraction \[LVEF\] \< 30%) or acute pulmonary edema;
5. Severe hepatic insufficiency (Child-Pugh score ≥ C, or aspartate aminotransferase \[AST\] \> 5× upper limit of normal); severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] ≤ 30 mL/min/1.73 m²) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis;
6. History of prior coronary artery bypass grafting (CABG);
7. Severe allergy to iodinated contrast agents;
8. Inability to obtain high-quality imaging;
9. Pregnant or lactating females;
10. Concomitant diseases or limited life expectancy, quality of life, or functional status precluding further CAD evaluation;
11. Any other factors that, in the investigator's judgment, make the patient unsuitable for study enrollment, completion of the study, or follow-up.
Primary outcome measure(s)
Incidence of Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris — The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled. Major adverse cardiovascular and cerebrovascular events (MACCE), a pivotal composite endpoint in cardiovascular clinical trials, are defined as the aggregate occurrence of cardiovascular death, nonfatal ST - elevation or non - ST - elevation myocardial infarction (reflecting ischemic myocardial injury), nonfatal ischemic or hemorrhagic stroke (denoting cerebrovascular ischemia or hemorrhage), coronary revascularization (encompassing percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\] for obstructive coronary lesions), and unstable angina pectoris (characterized by new - onset or crescendo chest pain indicative of acute coronary syndrome without myocardial necrosis).
Trial sites (1)
Facility
City
Region
Status
Chuanbao Li
Jinan
Shandong
More Qilu Hospital of Shandong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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